Cleared Traditional

PROPARAFLU+ASSAY (K091053) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091053 · Prodesse, Inc. · Microbiology device
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Nov 2009
Decision
221d
Days
Class 2
Risk

K091053 is an FDA 510(k) clearance for the PROPARAFLU+ASSAY. Classified as Parainfluenza Multiplex Nucleic Acid Assay (product code OOU), Class II - Special Controls.

Submitted by Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 221 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Prodesse, Inc. devices

Submission Details

510(k) Number K091053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date November 20, 2009
Days to Decision 221 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 102d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OOU Parainfluenza Multiplex Nucleic Acid Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Parainfluenza Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Parainfluenza 1 Virus, Parainfluenza 2 Virus, Parainfluenza 3 Virus And Parainfluenza 4 Virus Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Human Parainfluenza Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Parainfluenza Infections If Used In Conjunction With Other Clinical And Laboratory Findings.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.